REGULATORY FILES

CONTEXT: You would like to submit an application for authorisation of a health claim to be scientifically validated by the European Food Safety Authority. The evidence for substantiation of the requested health effect is based on unpublished data of clinical trials you performed and/or on published data available in the literature.

ORCHIDALI ACHIEVEMENT: We can prepare and write the full dossier according to the format and the scientific requirements from the technical guidance from the EFSA. We can also coach you if your researchers prefer to be in charge of the scientific writing. In any case, we will share with you our experience in scientific writing for regulatory purposes. We are used to perform comprehensive review of published data. We describe the search strategy and apply inclusion and exclusion criteria in order to select the relevant publications.

ORCHIDALI ASSET: We have already written several application files, some of which received a positive opinion from the EFSA and got the authorisation. We supported our customers throughout the different stages of the health claim authorisation procedure: during the submission to the national competent authority; during the scientific assessment by the EFSA, during the “stop the clock” if additional information is requested by the EFSA; during the discussions between the EU Commission and the Member States for adoption of the regulation.

PERSPECTIVES: Before writing the application file, we can check that the available evidence for substantiation of the claimed effect on health meets the standards of high scientific quality required by the EFSA. Orchidali has also experience in writing other regulatory dossiers such as for Food for Special Medical Purposes (FSPM), Infant Formula…